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Recruiting NCT05894863

Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions

No phase Interventional Peripheral Arterial Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smart flex stent.
Who it may be relevant to
Registry conditions: Peripheral Arterial Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Smart Flex Stent System for the Treatment Long Femoropopliteal Artery Lesions: the SAFARI Study

Overview

This study aims to evaluate the effectiveness and safety of the Smart flex stent system in treating long femoropopliteal native lesions.

Detailed description

One hundred twenty patients with lesion lengths longer than 15 cm will be included. Patients will be invited for a follow-up visit at 1, 6, 12, and 24-month post-procedure. The primary effectiveness endpoint of the study is the primary patency at 12 months. The primary safety endpoint is freedom of major adverse events (MAEs) at 12 months. Secondary endpoints include acute procedure success rate; primary patency rate at 1, 6, and 24 months; freedom from TLR at 1-, 6-, 12, and 24-month follow-up; primary and secondary sustained clinical improvements at 1-, 6-, 12- and 24-month follow-up; Freedom of MAEs at 1-, 6-,12- and 24- month follow-up; change of quality of life at 1-, 6-,12- and 24- month follow-up.

Interventions

  • Device Smart flex stent
    Smart flex stent will be used for femoropopliteal occlusive lesions.

Primary outcome measures

  • Primary patency [Time frame: 12-month]
  • Freedom of major adverse events (MAEs) [Time frame: 12-month]
Secondary outcome measures (6)
  • Acute procedure success [Time frame: 72-hour within procedure]
  • Primary patency [Time frame: 24-month]
  • Freedom from clinically directed target lesion revascularization [Time frame: 24-month]
  • Freedom of major adverse events (MAEs) [Time frame: 24-month]
  • Primary sustained clinical improvement [Time frame: 24-month]
  • Vasc quality of life score [Time frame: 24-month]

Eligibility criteria

Inclusion criteria

  • The patient presented a score from 2 to 5 following Rutherford classification
  • The patient is willing to comply with specified follow-up evaluations at the specified times
  • The patient is >18 years old
  • Patient understands the nature of the procedure and provides written informed consent before enrolment in the study
  • The patient has a projected life expectancy of at least 24 months
  • Before enrolment, the guidewire has crossed the target lesion
  • Target lesion length ≧150mm by angiographic estimation
  • Stenosis > 50% or occlusion in the femoropopliteal artery
  • There is angiographic evidence of patent distal popliteal artery and at least one distal runoff to the foot

Exclusion criteria

  • Previous bypass surgery or stenting in the target vessel
  • Patients who exhibit acute intraluminal thrombus at the target lesion vessel
  • Patients with known hypersensitivity or contraindication to any of the following medications: Nitinol-titanium, antiplatelet therapy, anticoagulants, or thrombolytics therapy
  • Pregnant women or Female patients with potential childbearing
  • Use of thrombectomy, atherectomy, or laser devices during the procedure
  • Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion
  • The patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
  • Significant renal dysfunction (Serum creatinine >2.0mg/dl)
  • Patient with Known allergy to contrast media

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital — Shanghai

Identifiers

NCT: NCT05894863 · The SAFARI Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗